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Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair

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ClinicalTrials.gov Identifier: NCT02162810
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : November 11, 2019
Sponsor:
Information provided by (Responsible Party):
Francis Schneck, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE March 11, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date November 11, 2019
Study Start Date  ICMJE May 2014
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2014)
  • Healing Outcomes after Hypospadias Repair [ Time Frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
  • Healing Outcomes after Hypospadias Repair postoperatively after stent removal [ Time Frame: 4 to 12 weeks ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus). Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
Original Primary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Healing Outcomes after Hypospadias Repair [ Time Frame: postoperative follow up 7-12 days after the surgery following completion of the 5-day course of prednisolone vs. placebo. ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
  • Healing Outcomes after Hypospadias Repair postoperatively after stent removel [ Time Frame: 4 to 12 weeks ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus). Late complications can occur. Therfore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
Change History Complete list of historical versions of study NCT02162810 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2014)
  • Healing Outcomes after Hypospadias Repair 6 months after surgery [ Time Frame: 6-months ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
  • Healing Outcomes after Hypospadias Repair Follow up after toilet training [ Time Frame: Approximately at 4 years of age ]
    i) the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus) Late complications can occur. Therefore, this needs to be evaluated at the specified interval. This is the standard of care at Children's Hospital of Pittsburgh of UPMC Pediatric Urology department.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
Official Title  ICMJE Effect of Steroids on Post-Operative Complications Following Proximal Hypospadias Repair
Brief Summary The primary objective of this study is to determine the efficacy of administering a course of postoperative oral steroids in pediatric patients undergoing proximal hypospadias repair as prevention against complications. Specifically, the study aims to assess if the steroids i) decrease the incidence of wound breakdown, fistula formation, stenosis or stricture formation, and the need for subsequent redo-hypospadias surgeries and/or fistula repairs and ii) improve the quality of wound healing including the overall cosmetic appearance of the phallus (i.e. location of the urethral meatus).
Detailed Description Hypospadias repair is a surgery that is, unfortunately, fraught with a high complication rate with problems that include urethrocutaneous fistula formation, complete wound breakdown, glans dehiscence, urethral diverticulum formation, retraction of the urethral meatus, urethral stricture, and meatal stenosis . Failure of a proximal hypospadias repair (i.e. the development of a post-operative complication) is unpredictable, and few modifiable risk factors having been identified. Complications necessitate subsequent surgical intervention for pediatric patients, which must be carried out under general anesthesia. Evidence regarding the harms of multiple general anesthetics for children is increasing. Additionally, with each surgical revision comes the morbidity associated with another post-surgical convalescence. Thus, any measure that can be gained as a way to increase the rate of success of proximal hypospadias repair would be of help to all pediatric urologists and patients with hypospadias. The proposed intervention of administering a 5 day course of placebo versus oral steroids at a dose equivalent to what is given for outpatient treatment of asthma exacerbations, is expected to have very low risk. This would be the only variation from the current practice and one that has never been studied in the past. Thus, it would be worthwhile to perform use scientific methods to determine if the administration of a short course of oral steroids is of benefit to healing and minimization of post-operative complications for hypospadias patients.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Condition  ICMJE Hypospadias
Intervention  ICMJE
  • Drug: Prednisolone
    In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
    Other Name: Steroid
  • Drug: placebo-controlled
    In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
    Other Name: Unknowen
Study Arms  ICMJE
  • Active Comparator: oral steroids
    Systemic high-dose steroids (30 mg/kg methylprednisolone) have been shown in a randomized, double-blind, placebo-controlled trial in humans not to negatively impact wound infection or dehiscence rates, instead benefitting patients in the postoperative period in ways such as decreasing pain. An acute course of oral systemic steroids has been routinely used in patients under the age of 12 with asthma exacerbations (liquid prednisolone at 1-2 mg/kg/day in 1-2 divided doses for up to 10 days, although usually given for 5 days, which is at least 19 times less than the dose proven to be safe in the randomized controlled trial mentioned above) and proven to be safe without adverse effects. Effect of prednisolone on the systemic response and wound healing after colonic surgery.
    Intervention: Drug: Prednisolone
  • Placebo Comparator: placebo-controlled
    Simple Syrup will be used as the placebo
    Intervention: Drug: placebo-controlled
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 10, 2014)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients undergoing proximal hypospadias repair

Exclusion Criteria:

  • All patients currently taking steroids at the time of surgery or during the six-week recovery period as well as patients with betamethasone hypersensitivity will be excluded from the study. Selection will be based on parent willingness to allow the child to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 3 Months to 22 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Jennifer Szczepaniak, BS 412-692-6203 jennifer.szczepaniak@chp.edu
Contact: Dawn McBride, RN,BSN 412-623-2764 mcbridedl@upmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162810
Other Study ID Numbers  ICMJE PRO14010275
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Francis Schneck, University of Pittsburgh
Study Sponsor  ICMJE Francis Schneck
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Francis Schneck, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP